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IRCT20210715051904N3 IRCT 2025-08-30 Boushehr University of Medical Sciences Mouthwash therapies for pediatric chemotherapy mucositis (MMT) Mucositis Mouthwash Trial Double-Blind Clinical Trial Evaluating the Effectiveness of Amphotericin B Mouthwash versus an Antacid–Nystatin–Diphenhydramine Mouthwash for Chemotherapy-Induced Mucositis in Pediatric Patients 2025-09-25 anticipated 40 Complete https://irct.ir/trial/85297 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to two intervention groups using block randomization with a block size of four to ensure balanced allocation. An independent statistician will generate the block randomization scheme using the free website, http://randomization.com. Allocation concealment will be maintained through the use of sequentially numbered, opaque, sealed envelopes (SNOSE) to prevent selection bias. After enrollment, a nurse not involved in the intervention or outcome assessment will sequentially open the next envelope to assign the participant to either Group A or Group B. The treating physician, responsible for preparing and administering the mouthwashes, will be aware of the group assignments for operational purposes but will not participate in outcome evaluations, Blinding description: The pediatric dental specialist conducting mucositis assessments will be blinded to group allocations to ensure unbiased outcome evaluations. Study participants, their legal guardians, and data analysts will remain blinded to the treatment assignments. Both mouthwashes will be dispensed in identical containers with neutral labeling to prevent detection of group assignment by participants or caregivers. Blinding effectiveness will be assessed midway through the study by querying assessors and participants regarding their perception of group allocation. 3 Pediatric cancer, Chemotherapy, mucositis. Intervention 1: Control Group: Participants in Group A will receive a compounded mouthwash containing 5 mL of diphenhydramine hydrochloride syrup (Darou Pakhsh Pharmaceutical Co., Tehran, Iran), 5 mL of magnesium–aluminum hydroxide antacid suspension (Loghman Pharmaceutical Co., Tehran, Iran), and 1 mL of nystatin oral suspension (100,000 units/mL, Jaber Ebne Hayyan Pharmaceutical Co., Tehran, Iran). The solution will be administered three times daily for 21 days, with each dose consisting of 7 mL. Participants able to gargle will rinse with the solution for 2 minutes and repeat the rinse after 15 minutes. For patients unable to gargle, caregivers will apply the solution to affected mucosal areas using sterile gauze. Mouthwashes will be freshly prepared every three days. Patients will be instructed not to swallow the solution and to avoid eating or drinking for at least 30 minutes after each use. To ensure blinding, all formulations will be dispensed in opaque, coded bottles. Intervention 2: Intervention Group: Participants in Group B will receive a mouthwash prepared by dissolving 50 mg of amphotericin B (Exir Pharmaceutical Co., Boroujerd, Iran) in 500 mL of 5% dextrose in water (Shahid Ghazi Pharmaceutical Co., Tabriz, Iran), resulting in a concentration of 0.1 mg/mL. The solution will be administered three times daily for 21 days, with each dose consisting of 7 mL. Participants who can gargle will rinse for 2 minutes, followed by a second rinse after 15 minutes. For participants unable to gargle, caregivers will apply the solution by gently swabbing the affected mucosal areas with sterile gauze soaked in the mouthwash. Mouthwash solutions will be freshly prepared every three days. Participants will be instructed not to swallow the solution and to avoid eating or drinking for at least 30 minutes after application. To ensure blinding, the mouthwash will be dispensed in opaque, coded bottles. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Nader Shakibazad
Tabib Medical Building (9th floor), Keshtirani crossroads, Boushehr,
Boushehr Iran (Islamic Republic of) 7514799621 +98 77 3335 1048 nshakibazad@gmail.com Boushehr University of Medical Sciences scientific Nader Shakibazad
Tabib medical building (9th floor), Keshtirani crossroads, boushehr
Boushehr Iran (Islamic Republic of) 7514799621 +98 77 3335 1048 nshakibazad@gmail.com Boushehr University of Medical Sciences Iran (Islamic Republic of) Age between 6 and 18 years Diagnosis of chemotherapy-induced oral mucositis (Grade 2 or 3) based on WHO criteria. No other local etiologies for mucositis (e.g., trauma, vitamin deficiencies) Signed informed consent by legal guardians and patient assent 6 years 18 years Both Inability to cooperate with the treatment regimen Known hypersensitivity or allergy to Amphotericin B, antacids, nystatin, or diphenhydramine. Use of methotrexate chemotherapy Severe leukopenia (WBC<500 cell/micoliter) K12.31 Oral mucositis (ulcerative) due to antineoplastic therapy Treatment - Drugs Treatment - Drugs Control Group: Participants in Group A will receive a compounded mouthwash containing 5 mL of diphenhydramine hydrochloride syrup (Darou Pakhsh Pharmaceutical Co., Tehran, Iran), 5 mL of magnesium–aluminum hydroxide antacid suspension (Loghman Pharmaceutical Co., Tehran, Iran), and 1 mL of nystatin oral suspension (100,000 units/mL, Jaber Ebne Hayyan Pharmaceutical Co., Tehran, Iran). The solution will be administered three times daily for 21 days, with each dose consisting of 7 mL. Participants able to gargle will rinse with the solution for 2 minutes and repeat the rinse after 15 minutes. For patients unable to gargle, caregivers will apply the solution to affected mucosal areas using sterile gauze. Mouthwashes will be freshly prepared every three days. Patients will be instructed not to swallow the solution and to avoid eating or drinking for at least 30 minutes after each use. To ensure blinding, all formulations will be dispensed in opaque, coded bottles. Intervention Group: Participants in Group B will receive a mouthwash prepared by dissolving 50 mg of amphotericin B (Exir Pharmaceutical Co., Boroujerd, Iran) in 500 mL of 5% dextrose in water (Shahid Ghazi Pharmaceutical Co., Tabriz, Iran), resulting in a concentration of 0.1 mg/mL. The solution will be administered three times daily for 21 days, with each dose consisting of 7 mL. Participants who can gargle will rinse for 2 minutes, followed by a second rinse after 15 minutes. For participants unable to gargle, caregivers will apply the solution by gently swabbing the affected mucosal areas with sterile gauze soaked in the mouthwash. Mouthwash solutions will be freshly prepared every three days. Participants will be instructed not to swallow the solution and to avoid eating or drinking for at least 30 minutes after application. To ensure blinding, the mouthwash will be dispensed in opaque, coded bottles. Time to complete resolution of oral mucositis. Timepoint: Evaluation will be performed every 3 days from the beginning of the intervention until complete recovery (grade 0 mucositis) or up to 21 days after the start of treatment. Method of measurement: Clinical examination by a blinded pediatric dental specialist using the WHO Oral Mucositis Grading Scale: Grade 0: No mucositis. Grade 1: Soreness and/or erythema. Grade 2: Erythema and ulcers, patient able to swallow solid foods. Grade 3: Ulcers, patient limited to a liquid diet. Grade 4: Severe ulceration, alimentation impossible, requiring enteral or parenteral support. Lesion size will be measured using calibrated millimeter paper (±1 mm accuracy). Incidence of adverse events related to mouthwash use. Timepoint: Monitored continuously throughout the 21-day intervention. Method of measurement: Patient/caregiver-reported symptoms recorded at each clinical visit and spontaneous reporting. Boushehr University of Medical Sciences Approved 2023-10-29 Ethics Committee of Bushehr University of Medical Sciences Campus of Medical Sciences, Salman Farsi Street, Bahmani, Bushehr Boushehr Boushehr Iran (Islamic Republic of)